United States regulators have given approval for Elon Musk's start-up Neuralink to test its brain implants on people. Neuralink said on Thursday that it received clearance from the US Food and Drug Administration (FDA) for the first human clinical study of implants which are intended to let the brain interface directly with computers. "We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study," Neuralink said in a post on Twitter – which is owned by Musk. Neuralink prototypes, which are the size of a coin, have so far been implanted in the skulls of monkeys, demonstrations by the startup showed. With the help of a surgical robot, a piece of the skull is replaced with a Neuralink disk, and its wispy wires are strategically inserted into the brain, an early demonstration showed.
Elon Musk's Nueralink will not be testing its brain implant on humans anytime soon - the US Food and Drug Administration (FDA) has rejected the company's application. The agency outlined dozens of issues the company must address before human testing, a critical milestone for final product approval, Neuralink staffers told Reuters. The concerns include the device's lithium battery; the potential for the implant s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue, the employees said. Musk applied in early 2022, but staffers said the company co-founder has yet to solve all the problems - even though the billionaire revealed human trials would start in six months back in November. Three staffers said they were skeptical the company could quickly resolve the issues.
Elon Musk's Neuralink is under federal investigation for animal-welfare violations amid staff complaints that its animal testing is being rushed, causing needless suffering and deaths, according to a Reuters review of documents and sources familiar with the investigation and company operations who spoke to Reuters. Neuralink, a medical devices company, is developing a brain implant it hopes will help paralyzed people walk again and cure other neurological ailments. The federal probe, which has not been previously reported, was opened in recent months by the U.S. Department of Agriculture's Inspector General at the request of a federal prosecutor, according to two sources with knowledge of the investigation. It comes amid growing employee dissent about Neuralink's animal testing, including complaints that pressure from CEO Musk to accelerate development has resulted in botched experiments, according to a Reuters review of dozens of Neuralink documents and interviews with more than 20 current and former employees. Elon Musk's Neuralink is facing a probe amid reports of botched animal testing according to Reuters In all, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018, according to records reviewed by Reuters and sources with direct knowledge of the company's animal-testing operations.
Elon Musk's Neuralink is under federal investigation for animal-welfare violations amid staff complaints that its animal testing is being rushed, causing needless suffering and deaths, according to a Reuters review of documents and sources familiar with the investigation and company operations who spoke to Reuters. Neuralink, a medical devices company, is developing a brain implant it hopes will help paralyzed people walk again and cure other neurological ailments. The federal probe, which has not been previously reported, was opened in recent months by the U.S. Department of Agriculture's Inspector General at the request of a federal prosecutor, according to two sources with knowledge of the investigation. It comes amid growing employee dissent about Neuralink's animal testing, including complaints that pressure from CEO Musk to accelerate development has resulted in botched experiments, according to a Reuters review of dozens of Neuralink documents and interviews with more than 20 current and former employees. In all, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018, according to records reviewed by Reuters and sources with direct knowledge of the company's animal-testing operations.
Neuralink Corp., Elon Musk's brain-implant company, said it received approval from the US Food and Drug Administration to conduct human clinical trials. "This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people," the company said Thursday in a tweet. The FDA and Neuralink did not immediately respond to requests for comment. Musk's startup is developing a small device that will link the brain to a computer, consisting of electrode-laced wires. Placing the device requires drilling into the skull. The approval "is really a big deal," said Cristin Welle, a former FDA official and an associate professor of neurosurgery and physiology at the University of Colorado.